Investor Presentaiton
SP0125 demonstrated safety profile similar to placebo
sanofi
First administration
Participants experiencing at least one
unsolicited AE within 28 days after vaccination
RSVt LD
(n=61)
RSVt HD
(n=57)
Placebo
(n=61)
RSVt LD
(n=48)
Second administration
RSVt HD
(n=48)
Placebo
(n=54)
n (%)
n (%)
Not related to vaccination
37 (60.7)
30 (52.6)
n (%)
38 (62.3)
n (%)
22 (45.8)
n (%)
17 (35.4)
Related to vaccination
5 (8.2)
6 (10.5)
4 (6.6)
4 (8.3)
3 (6.3)
n (%)
23 (42.6)
2 (3.7)
AE of special interest*
15 (24.6)
8 (14.0)
15 (24.6)
7 (14.6)
5 (10.4)
6 (11.1)
Medically attended AE
28 (45.9)
23 (40.4)
26 (42.6)
19 (39.6)
14 (29.2)
17 (31.5)
AE leading to study discontinuation
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
1 (1.6)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
Serious AE
Death
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
* Based on investigator assessment. AE of special interest: acute otitis media, upper and lower respiratory infections.
33 Vaccines Investor EventView entire presentation